The U.S. Food and Drug Administration (FDA) recently issued a new draft guidance (2011 Version) to clear up confusion about what types of changes to existing medical devices require new 510(k) submissions and update its 1997 guidance document, "Deciding When to Submit a 510(k) for a Change to an Existing Device."

Background

Under FDA regulations (21 CFR 807.81(a)(3)), a new 510(k) must be submitted when changes are significant enough to meet the following criteria:

  • A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process or
  • A major change or modification in the intended use of the device.  

The original 1997 guidance document, and now this 2011 Version, have been published with the intent of clarifying the subjective regulatory language above in an effort to improve predictability, consistency, and transparency of the premarket review program.

Comparison of 2011 Draft Guidance to 1997 Guidance

While there are indeed similarities between the 2011 Version and its 1997 predecessor, the notable differences are outlined here:

Manufacturing Process Changes

The 2011 Version adds a Manufacturing Process Changes section not found in the 1997 guidance to clarify specifically that:

  • If manufacturing processes were not factored into the original 510(k) submission review, changes in the manufacturing process will likely not require a new submission. However, when a review of the manufacturing processes was factored into the original submission, any changes to manufacturing processes that could affect device specifications will likely require submission of a new 510(k).  

Labeling Changes

The 2011 Version expands the threshold for new 510(k) submissions for label modifications to the following:

  • The scope of labeling is expanded to more than just instructions, to “all written, printed, or graphic matter on or accompanying a medical device.”
  • Where the 1997 guidance did not require new 510(k) submission when a “device was cleared for use with three specific indications and the firm decides to market the device for only two of those indications,” the 2011 Version notes that in the case where a device is marketed for less than the number of indications it was cleared for, it would have to submit a new 510(k) if it was due to a reason besides changes in market demand, for example, changes that have been made to because of complaints.
  • The 1997 guidance clarified that a 510(k) submission is not necessary when a prescription device label is changed to allow for home-use, but the 2011 Version explicitly requires a new 510(k) submission in such instances.

Technology, Engineering, and Performance Changes

As in the 1997 guidance, the 2011 Version clarifies when a new 510(k) submission should be submitted for modifications to device technology, engineering, and performance. The 2011 draft guidance, however, covers many more types of technological changes used by medical devices. For example:

  • The 2011 Version clarifies that when a modification allows for a device to provide new output data, even from the same input data, which is used for diagnostic purposes, a 510(k) submission is required because such change would introduce new risks for the device and significantly impact safety and effectiveness.
    • Example: when a device that previously only displayed an image of blood flow is modified to also display quantitative assessments along with the image.
  • In general, most technology modifications will require a 510(k) submission.
  • FDA chose not to address issues concerning nanotechnology, and recommends that manufacturers contact the agency directly to work out any nano-related changes.

Materials Change

Less detailed than in the 1997 guidance, the 2011 Version clarifies that a new 510(k) submission is not generally required when the changed material does not make direct or indirect contact with the patient.

The draft guidance document listing the device types to be exempted can be found on the FDA’s website. FDA is seeking further comment on the draft guidance from stakeholders.